Real-World Results of Gilead’s Biktarvy Show Long-Term Efficacy, Safety Profile

Gilead Sciences Inc presented real-world results from the BICSTaR study (NCT03580668), evaluating bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets (B/F/TAF) (Biktarvy) in individuals with HIV.

Investigators found that the last 5-years of data from 2 phase 3 studies (NCT02607956 and NCT02607930) showed evidence of the long-term efficacy and safety profile of B/F/TAF in those who switched from a dolutegravir-containing regimen.

The data were presented at the 30th International Congress on Drug Therapy in HIV Infection.

“These latest data demonstrate how innovation and improvement in HIV treatment options can help [individuals] living with HIV and their [physicians] identify an HIV treatment regimen that supports their treatment over the long-term,” Benoit Trottier, MD, director of research at Clinique de Médecine Urbaine du Quartier Latin in Montreal, Canada, said in a statement.

“Factors such as aging and comorbidities are vital components of long-term health discussions. The BICSTaR study reinforces the real-world effectiveness of [B/F/TAF] across populations with a range of comorbidities, and the findings are consistent with evidence from randomized clinical trials of [B/F/TAF] treatment,” Trottier said.

The data were presented from the 24-month BICSTaR follow-up analysis, which evaluated the effectiveness and safety of the drug in clinical practice across 9 countries.

The analysis included a follow-up during the COVID-19 pandemic, and investigators adjusted for adherence, age, adherence, late diagnosis, race, and sex in the population group.

They found that the individuals who started treatment with B/F/TAF experienced high viral suppression. Overall, approximately 97% of individuals who were treatment-naïve and 95% of those who were treatment-experienced achieved viral suppression at 24 months.

There were no reports of treatment-emergent resistance. Approximately 14% of individuals discontinued treatment, and 7% discontinued B/F/TAF, because of drug-related adverse events (DRAEs).

The most commonly reported DRAEs were depression at 1% and weight change at 3%.

Investigators said the data reinforce the durability and safety of the drug for individuals with HIV who have many comorbidities.

Additionally, data from the other studies that were presented at the conference showed B/F/TAF to have high efficacy and sustained safety for those who were switching to treatment and even continued the high barrier to resistance of treatment.

The outcomes were reported in individuals 96 weeks after they switched to open-label B/F/TAF, following 144 weeks of blinded dolutegravir and 2 nucleoside/nucleotide reverse transcriptase inhibitors.

At week 240, approximately more than 99% of individuals in both studies achieved viral suppression. The data also demonstrated that the switch to B/F/TAF was greater than 96% effective and showed that it could provide sustained viral suppression even after switching treatments.

In both studies, it was generally well tolerated, with 0.4% of individuals in both studies experiencing an AE that led to drug discontinuation.

The most commonly reported AEs during the open-label extension phase were diarrhea at 0.6% and weight change at 0.6%.

On October 14, 2022, the FDA approved a label change for B/F/TAF, updating the prescribing information to include efficacy data from 144 weeks and safety data from 240 weeks of clinical trial results of individuals with HIV who were initiating therapy.

Reference

Gilead presents real-world evidence reinforcing the use of Biktarvy for the treatment of individuals living with HIV with a range of comorbidities. News release. Gilead Sciences. October 24, 2022. Accessed October 24, 2022. https://www.gilead.com/news-and-press/press-room/press-releases/2022/10/gilead-presents-real-world-evidence-reinforcing-the-use-of-biktarvy-for-the-treatment-of-people-living-with-hiv-with-a-range-of-comorbidities